Kornimate/medical-research-clean huggingface dataset:
evaluation of fiasp® (fast acting insulin aspart) in 670g hybrid closed-loop therapy

Conditions: Diabetes Mellitus, Type 1

Summary: this is a pilot outpatient study conducted at stanford to obtain preliminary data on how fiasp® works in a closed-loop system and to determine if any changes need to be made to the 670g pump to optimize the use of fiasp®.

this will be a randomized cross-over blinded study and to see how the 670g pump responds to the introduction of fiasp® insulin. subjects enrolled in the study will have a 2 week period of optimization with weekly assessments of their carelink download before entering the blinded phase of the study. they will use their usual home insulin during the optimization phase. they will then be started on their first blinded insulin (aspart or fiasp®) which they will use for 2 weeks, before they cross-over to the other insulin.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of type 1 diabetes and using 670g pump for at least 1 month, and willing to have the 670g pump downloaded into a carelink clinical research database. 2. the diagnosis of type 1 diabetes is based on the investigator's judgment; c-peptide level and antibody determinations are not needed. 3. age ≥18 years 4. using novolog or fiasp® insulin at time of enrollment 5. willing to use fiasp® insulin 6. total daily insulin dose is at least 0.3 units/kg/day 7. usual carbohydrate intake is at least 60 grams a day, and willing to have at least 25 grams of carbohydrates for breakfast 8. for females, not currently known to be pregnant 9. an understanding of and willingness to follow the protocol and sign the informed consent 10. willing to have photographs taken of their infusion sites 11. willing to download their 670g pump every 1-2 weeks to a research carelink account 12. willingness to answer a brief online questionnaire every 2 weeks 13. must be able to understand spoken or written english 14. for subjects participating in part 2 of this study they will need to be using fiasp® as part of their usual care 15. hemoglobin a1c between 6 and 10% at the time of enrollment exclusion criteria: 1. pregnant or lactating females 2. no hypoglycemic seizure or loss of consciousness in the past 6 months 3. severe episode of dka in the 6 months prior to study enrollment that was unrelated to an infusion set failure 4. no known cardiovascular events in the last 6 months 5. no active proliferative diabetic retinopathy 6. known tape allergies 7. current treatment for a seizure disorder 8. cystic fibrosis 9. active infection 10. a known medical condition that in the judgment of the investigator might interfere with the completion of the protocol 11. inpatient psychiatric treatment in the past 6 months 12. presence of a known adrenal disorder 13. if on antihypertensive, thyroid, anti-depressant or lipid lowering medication, with lack of stability on the medication for the past 2 months prior to enrollment in the study 14. abuse of alcohol 15. dialysis or renal failure 16. known egfr \<60% note: adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
identification and management of comorbidities and extra-intestinal manifestations in crohn's disease: the nemo nurse-led program

Conditions: Crohn Disease

Summary: crohn's disease (cd) is a chronic inflammatory disease of the gastrointestinal (gi) tract. although inflammation is predominantly expressed in the gi tract, extra-intestinal manifestations (eims) are so frequent that the concept of systemic disease is now widely accepted. moreover, similar to other chronic diseases, patients with cd can be affected by other unrelated diseases which are called comorbidities. although no specific guidelines on comorbidity and eims in cd are available, data from other immune-mediated diseases support the use of nurse-led programs to improve the cost-effectiveness for the management of cardiovascular risk factors, increase rates of pneumococcal vaccination in high-risk patients, provide preventive measures against osteoporosis and increased fracture risk in older women. the investigators believe that such an initiative can be conducted for cd patients by developing a cd-specific nurse-led program. moreover, it has been shown that cd patients highly appreciate the "communicator role" and "skilled companionship" performed by nurses to fulfill their needs for attention to the "complete picture". therefore, the investigators hypothesize that a nurse-led program would increase the number of measures taken to treat or identify eims and/or comorbidities in cd patients and thus revolutionize their management.


Eligibility criteria:
inclusion criteria: * established diagnosis of cd with a minimum disease duration of 3 months * cd considered by the treating gastroenterologist to have been stable for at least 3 months * no surgery planned within 6 months after the inclusion visit exclusion criteria: * subject unable to attend all the study visits or comply with study procedures. * subject unwilling or not able to understand or sign the informed consent.
bioavailability study of oxandrolone tablets under fasting conditions

Conditions: To Determine the Bioequivalence Under Fasting Conditions

Summary: -to compare the single dose bioavailability of kali and btg

-to compare the bioavailability of oxandrolone 10mg tablets with that of oxandrin 10mg tablets following a single -dose in healthy, adult subjects under fasting conditions.

Eligibility criteria:
inclusion criteria: * healthy subject at least 18 years of age, may be male or they may be female who are unable to bear children. * each subject shall be given a general physical examination within 28days of the initiation study. * at the end of the study, the subjects will have an exit evaluation consisting of interim history, global evaluation, and clinical laboratory measurements. * each female subject will be given a serum test as part of the pregnancy study screening process. * clinical laboratory measurements will include hematology, clinical chemistry, urine analysis, hiv screen,hepatitis-b, c screen and drugs of abuse screen exclusion criteria: * subjects with a history of alcoholism or drug addiction(during past 2 years), or serious gastrointestinal, renal hepatic or cardiovascular disease, tuberculosis, epilepsy. asthma, diabetes, psychosis or glaucoma will not be eligible for thsi study. * subjects with any history of breast or prostate cancer will not be eligible to participate in this study. * subjects who have a history of allergic response to the class of drug being tested will be excluded from the study. * subjects found to have urine/saliva concentration of any of the tested drugs will not be allowed to participate. * subjects who have taken any investigational drug within thirty days prior to the first dosing of the study will not be allowed to participate. * female subjects who are not able to bear children will not be allowed to participate. * female subjects with positive or inconclusive results will be withdrawn from the study.

Keywords: bioequivalence, oxandrolone,fasting
a phase 3b randomized, double-blind, multi-center study to compare the safety and efficacy of omadacycline to moxifloxacin for treating adult subjects with cabp

Conditions: Community-acquired Bacterial Pneumonia

Summary: the primary objective of the study is to show that in chinese adults with cabp, a course of iv/po treatment with omadacycline has similar clinical efficacy as the with the comparator antibiotic, iv/po moxifloxacin. the study is designed as a bridging study, to confirm the results of the pivotal global cabp trial in an ethnically different population of chinese.


Eligibility criteria:
inclusion criteria: 1. written and signed informed consent obtained before any protocol specific assessment is performed. 2. male or female, ages 18 years or older. 3. has at least 3 of the following symptoms: * cough * production of purulent sputum * dyspnea (shortness of breath) * chest pain 4. has at least 2 of the following abnormal vital signs: * fever or hypothermia documented by the investigator (temperature \> 38.0°c or \< 36.0°c) * hypotension with systolic blood pressure (sbp) \< 90 mmhg * heart rate (hr) \> 90 beats per minute (bpm) * respiratory rate (rr) \> 20 breaths/minute exclusion criteria: 1. has received antibacterial treatment \>24hr within the 72hr window prior to randomization. subjects may be eligible despite prior antibacterial therapy if they had been treated with short action time antimicrobial for ≤24h, or if they have received \> 48 hours of prior systemic antibacterial therapy for the current episode of cabp with unequivocal clinical evidence of treatment failure. 2. is known or suspected to have cabp caused by a pathogen that may be resistant to either test article (eg, klebsiella pneumoniae, pseudomonas aeruginosa, pneumocystis jiroveci, obligate anaerobes, mycobacteria, fungal pathogens). 3. suspected or confirmed empyema (a parapneumonic pleural effusion is not an exclusion criteria) or lung abscess. -
covid-19 infection and pulmonary distress treatment with zanubrutinib in hospitalized participants

Conditions: COVID-19 Pulmonary Complications; COVID-19

Summary: the primary objective of this study was to evaluate if the addition of zanubrutinib to supportive care increases the respiratory failure-free survival rate at day 28 in participants hospitalized for corona virus disease 2019 (covid-19) and pulmonary distress not receiving mechanical ventilation.


Eligibility criteria:
key inclusion criteria: 1. hospitalization for covid-19 infection 2. severe acute respiratory syndrome coronavirus (sars-cov)-2 infection confirmed by polymerase chain reaction (pcr) 3. participant requires supplemental oxygen for pulmonary distress related to covid-19 infection, and has been on supplemental oxygen for no more than 96 hours from time of screening key exclusion criteria: 1. malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction 2. on a bruton's tyrosine kinase (btk) inhibitor 3. planned or concurrent use of a host modifiers/immune-based therapies or anti-cd20 monoclonal antibody treatment 4. participants with prior of current hematologic malignancy or solid tumor malignancy with treatment within 6 months prior to study entry note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: corona virus covid-19
desflurane vs. sevoflurane in endovascular aortic repair

Conditions: Renal Failure

Summary: randomized clinical trial following the evaluation of the impact on renal function in patients undergoing endovascular aortic aneurysm repair with two anesthetics protocols (desflurane versus sevoflurane) on the first 24 hours after surgery.

randomized clinical trial to evaluate the impact on renal function in patients undergoing endovascular aortic aneurysm repair with two anesthetics protocols (desflurane versus sevoflurane) on the first 24 hours after surgery. secondary endpoint: among secondary endpoints we will evaluate clinical variables such emergence and recovery characteristics (time to extubation and time to emergence-open eyes and response to verbal command), the need for postoperative mechanical ventilation, the post-anesthesia recovery score and icu length of stay.

Eligibility criteria:
inclusion criteria: * older than 18 years undergoing elective endovascular aortic repair * who have signed informed consent exclusion criteria: * urgent surgery * with known hypersensitivity to desflurane or sevoflurane. * renal failure in hemodialysis

Keywords: desflurane, sevoflurane, endovascular aortic repair
spyral dystal renal denervation global clinical study

Conditions: Hypertension; Vascular Diseases; Cardiovascular Diseases

Summary: the objective of this single arm interventional study is to determine if renal denervation performed in the distal main and first order branch renal arteries is as effective in reducing blood pressure as the procedural approach used in the spyral htn-off med clinical study.


Eligibility criteria:
inclusion criteria: - individual has office systolic blood pressure (sbp) ≥ 150 mmhg and \<180 mmhg and a diastolic blood pressure (dbp) ≥ 90 mmhg after being off medications. * individual has 24-hour ambulatory blood pressure monitoring (abpm) average sbp ≥ 140 mmhg and \< 170 mmhg. * individual is willing to discontinue current antihypertensive medications exclusion criteria: * individual has estimated glomerular filtration rate (egfr) of \<45. * individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus. * individual has one or more episodes of orthostatic hypotension. * individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea. * individual has primary pulmonary hypertension. * individual is pregnant, nursing or planning to become pregnant. * individual has frequent intermittent or chronic pain that results in treatment with nonsteroidal anti-inflammatory drugs (nsaids) for two or more days per week over the month prior to enrollment. * individual has stable or unstable angina within 3 months of enrollment, myocardial infarction within 3 months of enrollment; heart failure, cerebrovascular accident or transient ischemic attack, or atrial fibrillation at any time. * individual works night shifts.

Keywords: uncontrolled hypertension renal denervation
clinical presentations, microbiology, antibiotic resistance patterns and management outcomes of culture-proven infection among adolescent and adult in a tertiary hospital in saudi arabia

Conditions: Culture-proven Infection

Summary: the characteristics of patients as well as microbiologic profile of culture-proven infection will be studies in conjunction with clinical outcome within 28-days


Eligibility criteria:
inclusion criteria: * any individual aged ≥13 year old requested for him/her bacterial/fungal culture. * able to provide a written informed consent. exclusion criteria: * age \<13 years old. * unable/unwilling to provide a written informed consent.
relationship between muscle strength and quality of life in icu survivors

Conditions: Critical Illness; Muscle Strength; Quadriceps Strength; Grip Strength; Quality of Life

Summary: the aim is to study the impact of muscle strength measured in icu and after icu discharge on health-related quality of life measured after hospital discharge.


Eligibility criteria:
inclusion criteria: * critically ill patients with an icu stay of at least 7 days * collaborative exclusion criteria: * non collaborative, confusion, coma * limb paresis or plegia * patient refusal
the effect of calisthenic exercise on aerobic capacity, muscle strength and quality of life in hemodialysis patients

Conditions: Physical Activity; Patient; Quality of Life; Hemodialysis

Summary: the aimed this study is to examine the effects of calisthenic exercises on aerobic capacities, muscle strength and quality of life in patients receiving hemodialysis treatment.

the study is a randomized single-blind placebo-controlled study. . at the beginning and end of the study, all patients will be asked to answer questions including demographic information and a quality of life questionnaire for kidney patients. a 6-minute walking test and a 30-second sit-stand test will be applied by the research physiotherapist to measure their aerobic capacity. again, a dynamometer will be used to measure muscle strength. the hypotheses the investigators will test for this purpors; h0 calisthenic exercise in hemodialysis patients increases aerobic capacity. h1calisthenic exercise in hemodialysis patients increases muscle strength.h2 calisthenic exercise in hemodialysis patients improves the quality of life.

Eligibility criteria:
inclusion criteria: * being treated in the hemodialysis unit of aydın adnan menderes university faculty of medicine research and application hospital, * having good cognitive functions * not having regular exercise habits * not having a physical disability * being between 18-60 years old * speaking and understanding turkish * being willing to participate in the study exclusion criteria: * neurologically affected patients (such as cerebrovascular accident, gullian barre) * patients with musculoskeletal problems that prevent exercise * patients with advanced heart failure, patients with unstable angina pectoris * patients with chronic liver failure * patients with a history of cardiovascular events (recent within 12 months)

Keywords: exercise hemodialysis quality of life
an open-label, long-term, safety study of lasmiditan for the acute treatment of migraine

Conditions: Migraine Disorders

Summary: this is a prospective, randomized, open-label study in subjects with migraine who have completed the phase 3 studies, col mig 301/lahj (nct02439320) or col mig-302/lahk (nct02605174) or for a subset of lasmiditan-naïve subjects with migraine. the study is designed to evaluate the safety and tolerability of long-term intermittent use of lasmiditan 100 mg and of lasmiditan 200 mg, as the first dose and as a second dose, for the acute treatment of migraine. long term efficacy will also be evaluated.


Eligibility criteria:
inclusion criteria: * able and willing to give written informed consent and authorize health insurance portability and accountability act (hipaa). * completed col mig-301 or col mig-302 within the last 12 weeks. subjects that completed col mig-301 prior to col mig-305 being available will be allowed to enroll as long as enrollment occurs within 4 weeks of col mig-305 activation at their site. (note: additional subjects may qualify if they completed col mig-301 or col mig-302 \>12 weeks prior or if they have not participated in either prior study, but meet eligibility criteria outlined for col mig-302.) * females of child-bearing potential must be using or willing to use a highly effective form of contraception (e.g. combined oral contraceptive, intrauterine device (iud), abstinence or vasectomized partner). * able and willing to complete an electronic diary to record details of all migraine attacks treated with study drug. exclusion criteria: * any medical condition or clinical laboratory test which in the judgment of the investigator makes the subject unsuitable for the study. * pregnant or breast-feeding women. * women of child-bearing potential not using or not willing to use highly effective contraception. * participant is at imminent risk of suicide (positive response to question 4 or 5 on the columbia suicide severity rating scale (c-ssrs). * initiation of or a change in concomitant medication to reduce the frequency of migraine episodes since completing col mig-301/lahj (nct02439320) or col mig-302/lahk (nct02605174). * participation in any clinical trial of an experimental drug or device since completing eos/visit 2 of col mig 301/lahj (nct02439320) or col mig-302/lahk (nct02605174).
irinotecan and panitumumab as 3rd line treatment for mcrc without kras mutations

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of this study is to investigate the effect and the side effect profile of irinotecan and panitumumab administered every 3 weeks as 3rd line treatment for patients with metastatic colorectal cancer without kras mutations.

colorectal cancer is one of the most frequent types of cancer in denmark with approximately 3,400 diagnosed patients per year. the prognosis for these patients is still very poor and more than half of them will develop metastatic disease and thus be candidates for chemotherapy. in denmark 5-fu and oxaliplatin or irinotecan has been used for several years either as combination or mono therapy. in recent years biological antibodies targeted against egfr have been added to this treatment. a newly developed antibody is panitumumab, which enables treatment every 3 weeks instead of weekly administration. the effect of egfr activation is mediated through intracellular pathways involving the kras protein. it has been proven that a mutation of kras causes the kras protein to be constantly activated, and patients with these mutations do not benefit from antibodies against egfr. approximately 40% of the patients present these mutations.

Eligibility criteria:
inclusion criteria: * histologically verified adenocarcinoma in colon or rectum with metastatic spread. * no mutations in the kras gene. * resistance to 5-fu, oxaliplatin and irinotecan. * age ≥18 years. * ps 0-2. * measurable disease according to recist criteria. * haematology: neutrophilocytes ≥1.5 x 109/l, leukocytes ≥3.0 x 109/l, thrombocytes ≥100 and bilirubinaemia ≤3 x upper normal value. samples no more than 4 weeks old. * fertile women must present a negative pregnancy test and use secure birth control during and 3 months after treatment. * acceptance that blod and tissue samples are kept for subsequent investigation of biomarkers. * oral and written informed consent. exclusion criteria: * other malignant disease within the past 5 years, excl. non-melanoma skin cancer and carcinoma in situ cervicis uteri. * chemotherapy, radiotherapy or immunotherapy within the past 4 weeks. * verified or clinically suspected cns metastasis. * other experimental treatment. * serious medical disease according to investigator's judgement. * pregnant or breastfeeding women. * hypersensitivity to the active substance or to one or more of the auxiliary substances. * patients with interstitial pneumonitis or pulmonary fibrosis.

Keywords: kras
hydroxychloroquine and unexplained recurrent miscarriage

Conditions: Unexplained Recurrent Miscarriage

Summary: recurrent miscarriage affects women of childbearing age worldwide. vascular endothelial dysfunction and immunological impairment are associated with recurrent miscarriage to date, there is no effective or optimal therapeutic approach for these condition. hydroxychloroquine has endothelial protective action via ant diabetic, lipid lowering, antioxidant effects or direct endothelial protection. hydroxychloroquine is an antimalarial and immunomodulatory agent. in pregnancy, hydroxychloroquine is prescribed for inflammatory conditions associated with adverse perinatal outcomes such as systemic lupus erythematosus, antiphospholipid syndrome and placental inflammatory lesions such as chronic histiocytic intervillositis, hydroxychloroquine has therapeutic potential to improve placental function in pregnancies associated with heightened inflammation.


Eligibility criteria:
inclusion criteria 1. women aged between 20- 40 years inclusive. 2. body mass index (bmi) between 18.5 -35 kg/m2 3. had at least 2 previous miscarriage before 20 weeks 4. women willing to conceive. 5. regular ovulatory cycles. 6. no anatomical or endocrine cause of recurrent pregnancy loss. 7. women who have given their informed consent. 8. negative antibody test for antiphospholipid syndrome (lupus anticoagulant, anticardiolipin igm, igg, b2glycoprotein) exclusion criteria 1. women who are already pregnant. 2. known contraindication to a treatment by hcq (retinopathy, hypersensitivity to chloroquine or hcq, g6pd deficiency, acute intermittent porphyria, chronic liver or kidney insufficiency, extensive cutaneous psoriasis not controlled by local treatment, significant chronic digestive , hematologic disease epilepsy or psychotic disorders.) or known rare disorder of lactose metabolism . 3. patient already using hcq 4. patient not get pregnant after 12 months of hcq use.